Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
64
Countries
2
Sites
7
NRAS-mutant advanced cutaneous melanoma
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 May 2021 → 4 Sep 2025
- Decision date (initial)
- 2023-11-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-503107-21-00
- EudraCT number
- 2020-003674-41
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
NRAS-mutant advanced cutaneous melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4990
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 12 | 5 |
| Norway | Ended | 3 | 2 |
| Rest of world
Korea, Republic of, United States, Australia, Canada
|
— | 49 | — |
Investigational sites
Universitaetsklinikum Tuebingen AöR
Universitäts-Hautklinik, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Universitaetsklinikum Mannheim GmbH
Klinik für Dermatologie, Venerologie und Allergologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Wuerzburg AöR
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinik für Dermatologie und Venerologie; Alternate postcode: 20246, Martinistrasse 52, Eppendorf, Hamburg
Charite Universitaetsmedizin Berlin KöR
Charité Research Organisation GmbH, Hindenburgdamm 30, Lichterfelde, Berlin
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2021-10-01 | 2021-12-16 | 2024-02-06 | ||
| Norway | 2021-05-14 | 2022-08-30 | 2024-02-06 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-07 | Germany | Acceptable 2023-11-29
|
2023-11-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-22 | Germany | Acceptable 2023-11-29
|
2024-03-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-11 | Germany | Acceptable 2024-07-29
|
2024-07-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-20 | Germany | Acceptable 2024-07-29
|
2024-09-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-29 | Acceptable 2024-12-12
|
2024-12-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-31 | Acceptable 2025-03-27
|
2025-03-31 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-02 | Acceptable 2025-08-18
|
2025-08-20 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-22 | Germany | Acceptable 2025-08-18
|
2025-08-22 |